MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY®; I.V. SAFETY CATHETER

Model Number	4251601-020
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complaint is still under investigation.A follow-up report will be provided, as soon as investigation has been completed.This report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
Event or Problem Description
As reported by the user facility ((b)(4)): "cannula left in patients vein"."the cannula fell out when staff tried to re-insert it and the patient reported that the insertion site was painful.When staff examined the cannula that fell out, they found it was shorter than normal.Part of the cannula was still in the patient's vein.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Received 2pcs used capillary hub of introcan safety 3 pur 20g without packaging.The cannula hub and protective cap for both samples were not returned for investigation.From the observation on both sample there was no capillary tear off defect found.For sample 1 the capillary measure at 35mm while for sample 2 the capillary was measure at 25mm.It was believe that the customer was returning 2 different length of capillary.No others damages was found on the returns samples.The in-line test equipment is subject of a frequent calibration and a regular verification related to its proper function.Herewith potential malfunctions of the systems would be detected in-time and would be mitigated.Beside the automated 100% in-line test equipment, independent in-process quality controls and final controls on a random sample basis will be conducted by different teams on a regular basis within the production process.Herewith a systematic product defect would be detected.Tear off capillary defect most likely not appear to be attributed by manufacturing process as the defect is able to be detected by the in-line vision system.Damages induced after assembly process is not possible since the catheter had been protected with the protective cap.The complaint samples were inspected and found that there is 2 different length of capillary return which is 32mm and 25mm.However for both samples there is no capillary tear off defect.Furthermore, the complaint sample is a used product and no further investigation can be conducted and the exact cause of the failure could not be determined.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 13711262
• Report Number: 9610825-2022-00086
• Device Sequence Number: 5434371
• Product Code: DQR
• UDI-Device Identifier: 04046964478673
• UDI-Public: (01)04046964478673(17)250501(10)20E06G8911
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K982805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4251601-020
• Device Catalogue Number: 4251130-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown